Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi Dose Injection
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|ClinicalTrials.gov Identifier: NCT01941238|
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : April 7, 2015
Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump offers the advantage of flexibility and precision to administering insulin and has been proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). However, there are extremely limited studies on the difference between insulin pump compared to MDI on the incidence of hypoglycemia and other acute complications during fasting Ramadan
The investigators hypothesized that insulin pump would be associated with less hypoglycemic events during fasting Ramadan compared to MDI without deterioration in glycemic control. Results of this study are descriptive but will fill a current gap in knowledge and may contribute to development of future guidelines for the management of type1DM during Ramadan.
|Condition or disease|
|Type 1 Diabetes|
|Study Type :||Observational|
|Actual Enrollment :||142 participants|
|Official Title:||Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi-dose Insulin Injection|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||November 2014|
- Incidence of hypoglycemia [ Time Frame: 5 weeks ]Rates of hypoglycemia during fasting ramadan in insulin pump users and MDI users [Hypoglycemia defined as blood glucose level ≤ 70 mg/dl ( 3.9 mmol/l)]
- Number of fasting days lost [ Time Frame: 5 weeks ]To estimate the number of days they needed to brake their fast due to acute complications (hypoglycemia, severe hyperglycemia, or DKA).
- Glycemic control [ Time Frame: Two (2) months ]To assess the glycemic control in the two groups using HbA1c and Fructosamine assays.
- overnight hypoglycemia [ Time Frame: 5 weeks ]To estimate the rates of overnight hyperglycemia in both groups.
- Rate of acute complications [ Time Frame: 5 weeks ]To estimate presence of severe hyperglycemia and /or DKA episodes in both groups
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941238
|National Guards Hospital|
|Dammam, Saudi Arabia, 31412|